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Recall Observatory FDA recall evidence

Device product

Universal Femoral Sleeves - Product Usage: used primarily in revision surgeries with the S-ROM Noiles, LPS, SIGMA, and LCS Knee products.

Z-1103-2021

January 08, 2021

Class II

Product summary

Firm
DePuy Orthopaedics, Inc.
Event
Event 87189
Status
Terminated
Classification
Class II
Quantity
60 sleeves
Official record key
device-enforcement:Z-1103-2021

Official wording

Reason: The taper dimensions may be out of specification due to a production issue during the manufacturing of these lots.

Code information: Product No.: 129453216, 129453226, 129453236,129453246 Lot No.: J85Y90, J86T23, J86T20, J8790J, J85Y92

Distribution pattern: Worldwide distribution - US Nationwide distribution in the states of AK, CA, FL, IN, MI, MN, MS, NC, NY, OH, PA, TX, VA and the countries of Canada, China, Germany, Puerto Rico, Switzerland.

Derived failure modes

  • Potency or specification failure

    reason.potency_specification_failure · v1.0.0

    out of specification